Part 1: Becoming informed about informed consent
“Every human being of adult years and sound mind has a right to determine what shall be done with his own body.”
Justice Benjamin Cardozo
Schloendorff v. Society of N.Y. Hosp. 211
N.Y. 125, 105 N.E. 92 (1914)
Informed consent has been around for a long time, and yet the concept of what it is and how best to use it still confuses many practitioners. Breaking down this legal doctrine into its individual elements is critical to understanding the risk management application of this basic fundamental legal and ethical principle. The easiest way to do this is to consider its legal application through a metaphor about dating.
“Whatcha doin’ later tonight? How about you and me getting together and see where the evening goes?”
First, one has to start by realizing that there is a difference between consent and informed consent. To put it into simple terms, if I ask you out on a date and you accept, you have just given me your consent to get together and do something. We don’t know what yet, but you have consented to accompanying me to do something. Whether we merely go out to dinner coupled with casual conversation, or we go back to my place for a dalliance of some sort is informed consent. In other words, before you can obtain patients’ informed consent to render specific treatment, you first must obtain their general consent for you to be their doctor.
Three elements are required for a patient’s consent to treatment to be deemed valid. First, it must first be given voluntarily. Second, the person granting the consent must be of legal age. Finally, this person must possess sufficient mental capacity. Let’s look at these a little closer and start with one’s mental capacity. While we all have patients whom we believe are “a few sandwiches short of a picnic,” the issue of one’s mental capacity in clinical orthodontics usually involves those with easily recognizable mental deficiencies or those who are impaired. Fortunately, we rarely encounter these issues in daily practice. Take, for example, patients (or parents) who show up at the consultation visit acting in a manner that would lead you to believe they were impaired secondary to drug or alcohol abuse. If they respond irrationally to the treatment plan you suggest, the issue of their capacity to grant consent, for themselves or for others in their charge, may come into play. You may also find this issue when dealing with the patient who voices totally unreasonable demands, is attempting to dictate inappropriate treatment, or who exhibits evidence of body dysmorphic syndrome.
The more common problems relating to consent fall into the other two categories. The legal age issue is far more common and arises in two contexts. First, when the patient is a minor, someone under the legal age of majority (usually 18), you must have the legal guardian’s consent to treat that child. Understand that at this point we are not talking about how we will treat the child; we are merely seeking permission to actually do something such as perform an examination or render emergency treatment for someone who is not a patient of record. If grandma, an aunt, the housekeeper, or even the non-custodial parent accompanies the minor to your office, you don’t technically have consent to render treatment. You can obtain general consent by phone, letter, or healthcare proxy, but make sure the legally recognized party is the one granting you consent to treat. A second example arises when you are treating a minor, and right in the middle of his orthodontic therapy, the patient turns 18, the legal age of majority. The patient says, “Take my braces off,” while mom retorts, “Over my dead body.” What do you do? Legally, the patient has the final say. To leave the braces on after a patient of legal age requests their removal is a battery — legally defined as the unauthorized, harmful, or offensive contact with another.
Finally, whether the consent was obtained voluntarily or not may turn on patients’ claiming that they were mentally coerced into accepting treatment. This can arise when patients are told something such as “If you don’t undergo orthodontic therapy, you will either lose these teeth from periodontal disease, suffer TMD problems, won’t be able to get a good job, never get a date for the prom,” etc. These remarks cannot be made if there is no clinical evidence to substantiate them or if they cannot be supported by scientific evidence. Nor can you imply that a patient’s self-image or facial esthetics are such that they will be socially ostracized or scorned because of “crooked teeth.” You cannot make untrue or unfounded statements that “bully, guilt, or guile” people into accepting orthodontic treatment.
“Great, so how about we go back to my place, open a bottle of wine, and see where the evening goes?”
So, now that you’ve consented to go out with me; let’s see, what shall we do? Aha, informed consent. Patients must be told in a language that they can both understand and comprehend such things as what the problem is, what you are going to do, how long treatment will take, what they can expect, what can go wrong, and how much it will cost. Sounds simple, right? Maybe, maybe not. Let’s take each item separately. But before we do that, there is just one more thing we must know: Which standard of care is applicable for disclosing this information? There are basically two standards for disclosure, and which one you are required to use depends upon which state you practice in. The more traditional standard is the professionally based one. Under this approach, the only information you need to disclose to your patients is the information that would be usually be disclosed by other doctors under the same or similar circumstances. In other words, the doctor decides what and how much to tell the patient. The more modern approach, followed by a majority of states, requires us to give patients all of the information that a reasonable person in the patient’s position would deem material in order to make a decision to accept or reject the proposed treatment. Ethically, the patient-based standard is the preferred alternative.
Looking further at the individual elements, one can see that patients who have a problem with the English language should be spoken to in their native tongue in order for them to understand what is being said. Next, be sure to speak in the nonclinical language and not in “Dentalese,” as this will help patients comprehend what you are telling them. To tell patients that they have a retrognathic mandible and aplasia of tooth No. 7, and that you recommend a vertical oblique ramus osteotomy with an implant prosthesis in the maxilla may be technically correct. However, it is infinitely more comprehensible to say that their bottom jaw is too small, they are missing an upper front tooth, and that the best way to solve their problem is by surgically bringing the bottom jaw forward and replacing the missing tooth with an implanted fake one. English, or whatever the patient’s native language is, ideally at the fourth to sixth grade level, is preferable to “Dentalese” at all times. You never want patients to say when they are claiming that there was a lack of informed consent, that yes, the doctor did say that, but I didn’t understand what he/she was saying.
Whatever treatment you are proposing may be clear-cut in your own mind, but you must learn to put yourself in the patient’s position. If any doctor were to recommend a certain procedure to be performed on you, I’m certain that being the intelligent person you are, you would want to know what your other treatment options or alternatives are. You would want to know what the risks are for each one, the consequences of doing x, y, or z, and what limitations may exist, etc. Why should our patients be different from us? They aren’t; and just because we are talking about teeth, doesn’t make it any different. Patients should also be apprised of all viable treatment alternatives, even if you don’t perform these procedures. Remember, it’s their bodies we are invading; only they can give us the right to trespass and in what way. Patients also have the right to know what will happen if they choose not to undergo treatment; for in most cases, as orthodontics is almost always elective in nature, this is another viable alternative.
How long treatment will take and how much it will cost are also factors involved in obtaining patients’ informed consent. It is a common presumptive mistake for the doctor to make unsubstantiated judgments as to what patients can or should be able to afford. The amount of time that treatment will take may be of major significance to some, while far less crucial for others. Your estimate of how long treatment will take should not “guild the lily” in the hope that the patient will not be turned off. We should not be engaging in paternalism by believing that we “know” that the treatment we are recommending is “the best thing for the patient.” The reason for this is that often our best intentions are not “the best thing for that particular patient” due individual idiosyncrasies, financial, or temporal hardships whether real or perceived.
Finally, patient must have the opportunity to ask and have answered all of their questions. Remember, we don’t give informed consent; we get it; the patients grant us their informed consent for the treatment being rendered. In other words it’s a two-way street; you provide patients with sufficient information, which in turn allows them to accept or reject the course of therapy you are recommending.
“Wow, you really got a date? What did you guys do?”
A frequently asked question is, What is the best way to document that you obtained the patients’ informed consent? Let’s go back to our analogy. If you had to, how would you prove what actually occurred or didn’t occur regarding your little assignation? This could be important. From an informed consent perspective, think of it as standing on a risk management ladder. The higher the rung you are on the ladder, the safer you are from the rising tide of accountability. Did you surreptitiously videotape the evening? That might be the best depicter, the highest rung on the risk management ladder. Some doctors do actually videotape their consultations to validate the verbal interaction. The next rung down on our risk management ladder is audiotaping what was discussed. Both of the scenarios offer wonderful proof of what was said, and they also prove what was not said. The third rung down is having the patients write in their own hand their understanding of the recommended treatment and what the risks and alternatives were. By doing this, they can never claim they didn’t understand what you told them; after all, they wrote it. Next would be a printed form of some type that is acknowledged via a signature. Following that would be a notation in the patient’s chart that some type of form or booklet of information was given, but without the patient’s signature. The next rung down is documenting in the chart what information you verbally told the patient or parent that is then “corroborated” by his/her signature or initial. This would again be followed by the same entry without such acknowledgment. No, you don’t need a patient’s signature; however, obtaining it places you one rung higher or the ladder. There is a legally accepted presumption that if something was written in the chart, it was said or done. The corollary also applies, if it was not written, that it was not said or done. Nearing the bottom of our risk management ladder, the patient’s record might say that the risks and alternatives were discussed without actually elaborating on the discourse. The next rung might merely note that informed consent was discussed. Finally, the last rung would evidence no indication of a consultation discussion — it’s your word against the patient’s.
“The evening takes a turn.”
Suppose my date and I agreed only to go out to dinner, but somewhere between salad and dessert, things changed, and the two of us decide to go back to her place for after-dinner drinks in her hot tub. Well, the same thing happens with informed consent; it is an ongoing process. Many doctors make the mistake of believing that if informed consent was obtained at the onset of treatment, their patients no longer have to be informed if negative sequelae start to occur. If, in the midst of treatment, you discover that root resorption, periodontal disease, and decalcifications are just beginning, you know that at some point a decision may have to be made to possibly discontinue active treatment prematurely even if the treatment goals have not been realized. Who makes that decision? If you say the doctor, you’re acting paternalistically again. If you say patients, how are they to know how far to go before you have to call it quits, and what are the ramifications of doing so? It should be obvious that the process of informed consent is an ongoing give-and-take between the doctor and patients based on what is occurring at any given point along the treatment time line. It is an ongoing exchange of information. Informed consent is continually given to allow you to continue on with treatment or to discontinue active therapy if the situation warrants it or if a patient demands treatment to be stopped for whatever reason. If that occurred, the reason should be documented to show that informed consent has been withdrawn. Either one can only occur based on the sufficiency of the information you provided.
“Who told you that?”
One more thing that needs to be discussed is who is allowed to give the required information and obtain patients’ informed consent? The bottom line is, it doesn’t matter. The information can be given by anyone in the office and in almost any medium. Each of us should develop our own style of information transmission. Some will go high tech via computer imaging, prepackaged interactive programs, or proprietarily produced videos. Others will discover that educational brochures or forms work best. For some, a good old-fashioned conversation with the patient is the way to go. How it is done and by whom (the doctor, treatment coordinator, assistant, front desk personnel, etc.) is totally irrelevant. The only thing that’s important is the sufficiency of the information provided. However you choose to undertake this duty should be reflective of your personality and conform to the socio-demographics of your patient population. Metropolis methodologies don’t always play well in “Smallville” and vice versa.
What did you think of our little date? Want to see me again? We can experience things you’ve never thought about … at least as far as risk management and chairside ethics in orthodontics is concerned.
Part 2: Application
In days of yore, when a new patient called for an initial appointment, many orthodontists sent a “welcome to our office” packet that usually included a letter thanking the patient for selecting their office as well as confirming the time of the patient’s appointment. Orthodontists might also have included a brochure about the office and the doctor, a map showing the office location, and possibly a health questionnaire to be filled out in advance. Today most of that is accomplished via a website. Either way, this is a good opportunity to start obtaining informed consent before you even meet the patient. Along with whatever other data is disseminated, consider using the following letter entitled “Your Right to Know,” or versions of it, as it sets the stage for an interactive relationship between the doctor and the patient.
Letter to the patient: your right to know
It’s been said “an informed consumer is our best customer.” This has never been truer than in the provision of healthcare services. What should you expect when you first visit an orthodontist? You should be told what the problem appears to be; what examinations are necessary to properly diagnose the problem and formulate a treatment plan; and in the case of a child, whether now is the appropriate time to begin therapy or whether it is best to wait until a future date to initiate treatment. Let’s look at these individually.
When patients either desire to have their teeth straightened or are informed that orthodontic therapy is recommended, they should be told why it is in their best interest to undergo such treatment. Some of the more common reasons for seeking treatment are:
- To improve cosmetics (crooked teeth, overbite, etc.)
- To facilitate other necessary dental work (to properly position teeth for capping, bridges, or implants)
- To correct a jaw discrepancy or skeletal disharmony (“one’s bite is off”)
- To help patients maintain their perio-dontal status (the health of the supporting gums and bone)
The next step is the gathering of necessary information by obtaining diagnostic records. Some doctors will obtain the required information at your initial visit while others will reappoint you for a records appointment. Either way, the most common records obtained are:
- A review of your medical and dental history as there are many underlying physical problems that can impact on the success or failure of orthodontic therapy.
- A comprehensive clinical exam to check for cavities, gum disease, and any other clinical manifestations that may have an impact on providing orthodontic treatment
- A cephalometric X-ray of the skull to see the relationship of the teeth to the jaws and the jaws to one another.
- X-rays of the teeth to determine how sound they are, whether the bony support for them is adequate, and what their positions and stage of development are relative to one another.
- Photographs of the face and teeth to assess a patient’s profile, bite, and the effect that any proposed tooth or jaw movement may have on him/her.
Following records acquisition, a chairside consultation between the doctor and the patient will either immediately occur, or you will be reappointed for a more formal consultation appointment.
At this consultation, your doctor should explain to you what the actual problem is in a language you can understand. You should be told why correction is advised and how it is to be achieved. You should also be informed of all reasonable alternative methods of resolving your particular problem. As no form of medical treatment is without the potential for some risks, limitations, or compromises, you should be made aware of those that pertain to your specific situation. Next, you should be told what result you can expect from undergoing orthodontic therapy; and finally, what will occur if no treatment is undertaken.
At this time, the fee for the services to be rendered should be discussed in full and suitable financial arrangements made to the satisfaction of both you and your doctor. Make sure that you have had the chance to ask and have answered all questions regarding the treatment plan proposed, how long it will take, as well as the financial responsibilities you are assuming. It is now time to begin treatment.
The appliances or braces will be specifically tailored to your particular problem. You may require permanent and/or removable appliances. Once the type of orthodontic appliances has been decided upon and you receive them, make sure you have been given careful instructions on how to care for them. Check to be sure that your doctor will either be available or will provide for coverage if an emergency (breakage) arises. You also need to be told that you have certain responsibilities to meet in order to achieve the best results possible. Some of these are maintaining good oral hygiene, wearing rubber bands as instructed, keeping your regularly scheduled appointments, etc. You must continue to see your general dentist at least twice a year unless your orthodontist recommends otherwise.
At the completion of active treatment, you will undergo a period of retention care. This phase of treatment is necessary to monitor and help maintain the results achieved. An appropriate retainer will be fabricated to maximize the stability of the finished result. Remember, nothing lasts forever, and some movement of your teeth over the years is normal and should be expected.
Orthodontic therapy carries many benefits. Evaluating these can be done only if you have been given sufficient information on which to base your decision to undergo care.
You have a right to know. To be educated is to be able to choose wisely.
Using the checklist
Once you have acquired whatever diagnostic records you need, your consultation is, in actuality, your informed consent discussion. A checklist of risk factors should be identified and individualized for each patient. In other words, while not all of these risks will happen to everyone, everyone should be aware that some of these commonly encountered risks may happen to them. Potential risks should not be transmitted in so overbroad a fashion that they become meaningless to any one individual; nor should they be presented in such graphic detail that patients will become confused or so put off or afraid of potential negative sequelae that they refuse the benefits of orthodontic therapy. Orthodontic-related risk factors should be case-specific. Since this is not always possible, it reinforces the notion of ongoing informed consent. Regardless of the medium used to dispense the required amount of information or the person appointed to disseminate it to the patient, it is universally accepted that at a minimum, the following information needs to be discussed.
The checklist on page 36 shows commonly encountered risk factors. The doctor should check off those that apply to the specifics of a patient’s case so that whoever is tasked with obtaining a patient’s informed consent can present the required information.
Obtaining informed consent, when done properly, can be a very rewarding practice, patient, and risk management procedure. It fosters a close doctor-patient relationship as all parties are now on the same track regarding the diagnosis, treatment plan, and prognosis. Your patients will understand and appreciate more of the complexities that are involved with their orthodontic treatment, thereby having a greater respect for the fees charged. It gives the doctor an aura of openness, honesty, and caring. All in all, if used as a sword and not a shield, obtaining informed consent will serve to benefit the patient, the doctor, and the profession through open communication.
One of our readers noted that in Pennsylvania, only the doctor can obtain a patient’s informed consent. In reviewing current Pennsylvania law, as stated in the MEDICAL CARE AVAILABILITY AND REDUCTION OF ERROR (MCARE) ACT; 40 Pa.C.S. § 1303.504(a); 2002, Dr. Jerrold is of the opinion that informed consent must be obtained BY THE DOCTOR only in the following circumstances:
Section 504. Informed consent.
(a) Duty of physicians.–Except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient’s authorized representative prior to conducting the following procedures:
(1) Performing surgery, including the related administration of anesthesia.
(2) Administering radiation or chemotherapy.
(3) Administering a blood transfusion.
(4) Inserting a surgical device or appliance.
(5) Administering an experimental medication, using an experimental device or using an approved medication or device in an experimental manner.
As routine orthodontics is NOT one of the ministrations noted in the above act, a patient’s informed consent for most orthodontic treatment would probably be valid if it were obtained by any qualified member of the orthodontic team BUT an argument could be made that the Statute might apply to an orthodontist when placing TADs, performing a CSF (Fiberotomy), performing any LASER procedure, or when trying any “widget or gizmo” in an “off label” or “experimental” fashion. We thank the reader for bringing this clarification to our attention.